Professionalism challenged by inadequate disclosure
MAYWOOD, Ill. -- Loyola University Hospital spine surgeon Dr. Alexander Ghanayem is co-author of a landmark editorial challenging the integrity of published industry-sponsored research involving a bone-growth product.
The unusually blunt editorial in The Spine Journal notes that in 13 trials involving 780 patients, industry-funded researchers did not report a single adverse advent involving Medtronic's Infuse® Bone Graft. (The product, approved for certain spinal-fusion surgeries, is designed to eliminate the need to harvest bone from the hip.)
The editorial in the nation's leading spine journal notes that the authors of nearly all the trials had financial ties with the manufacturer, with investigators earning as much as $26 million per study.
However, subsequent studies have documented serious adverse events, including inflammatory reactions, cancer, infection and implant dislodgement.
Flawed clinical research of the bone growth product and inadequate disclosure of industry relationships are examples of the problems arising from financial ties between physicians and the medical device and pharmaceutical industries.
"We find ourselves at a precarious intersection of professionalism, morality and public safety," the editorial states. "We work under a burden of suspicion that new technology research and publication is simply a 'broken system' as currently practiced. Our professionalism . . . is fundamentally challenged by the threat of 'tainted science.' "
The editorial goes on: "It harms patients to have biased and corrupted research published. It harms patients to have unaccountable special interests permeate medical research. It harms patients when poor publication practices become business as usual."
Researchers who have financial ties to industry often say they have too much integrity to allow industry funding to affect their objectivity. The editorial says this "choirboy defense" lacks even minimum credibility.
"Instead the press and public assume that multimillion-dollar compensation packages can and do alter the balance of objectivity."
Loyola University Health System (LUHS) is a member of Trinity Health. Based in the western suburbs of Chicago, LUHS is a quaternary care system with a 61-acre main medical center campus, the 36-acre Gottlieb Memorial Hospital campus and more than 30 primary and specialty care facilities in Cook, Will and DuPage counties. The medical center campus is conveniently located in Maywood, 13 miles west of the Chicago Loop and 8 miles east of Oak Brook, Ill. The heart of the medical center campus, Loyola University Hospital, is a 569-licensed-bed facility. It houses a Level 1 Trauma Center, a Burn Center and the Ronald McDonald® Children’s Hospital of Loyola University Medical Center. Also on campus are the Cardinal Bernardin Cancer Center, Loyola Outpatient Center, Center for Heart & Vascular Medicine and Loyola Oral Health Center as well as the LUC Stritch School of Medicine, the LUC Marcella Niehoff School of Nursing and the Loyola Center for Fitness. Loyola's Gottlieb campus in Melrose Park includes the 264-licensed-bed community hospital, the Professional Office Building housing 150 private practice clinics, the Adult Day Care, the Gottlieb Center for Fitness, Loyola Center for Metabolic Surgery and Bariatric Care and the Loyola Cancer Care & Research at the Marjorie G. Weinberg Cancer Center at Melrose Park.